Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359912
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-29
Brief Title:
Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells EPCs in Patients With Critical Limb Ischemia
Sponsor:
Allife Medical Science and Technology Co Ltd
Organization:
Allife Medical Science and Technology Co Ltd
Study Overview
Official Title:
Phase I Clinical Study on the Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells EPCs Injection in Patients With Critical Limb Ischemia
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells EPCs intravenous infusion to a subject with leg ulcer andor gangrene due to poor blood flow will be safe and if it will relieve leg pain increase blood flow andor cure the leg wound
Detailed Description:
Critical limb ischemia CLI is a progressive disease which arises as a result of atherosclerosis or vasculitis in leg arteries Prognosis of CLI is poor and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the leg arteries or frequent reocclusion following revascularization Therefore it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients The investigators will study the safety and clinical efficiency of vascular regeneration by means of transplantation of allogeneic Endothelial Progenitor Cells in patients with CLI who are not eligible for traditional revascularization treatments The primary endpoint is the safety and tolerance identified by adverse events related with investigated drugwhile the secondary endpoints are evaluation of the preliminary efficacy of EPCs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None